GB2465464A - Wireless device for confirmatory diagnosis of cystic fibrosis through analysis of sweat chloride - Google Patents

Wireless device for confirmatory diagnosis of cystic fibrosis through analysis of sweat chloride Download PDF

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Publication number
GB2465464A
GB2465464A GB0919789A GB0919789A GB2465464A GB 2465464 A GB2465464 A GB 2465464A GB 0919789 A GB0919789 A GB 0919789A GB 0919789 A GB0919789 A GB 0919789A GB 2465464 A GB2465464 A GB 2465464A
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United Kingdom
Prior art keywords
sweat
module
transmitter
analyzer
cystic fibrosis
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Withdrawn
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GB0919789A
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GB0919789D0 (en
Inventor
Alejandro Caceres Galvez
Rosa Passarell
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TECNICAS CIENTIFICAS PARA LABORATORIO SA
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TECNICAS CIENTIFICAS PARA LABORATORIO SA
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Publication of GB0919789D0 publication Critical patent/GB0919789D0/en
Publication of GB2465464A publication Critical patent/GB2465464A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045Devices for taking samples of body liquids
    • A61B10/0064Devices for taking samples of body liquids for taking sweat or sebum samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/42Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
    • A61B5/4261Evaluating exocrine secretion production
    • A61B5/4266Evaluating exocrine secretion production sweat secretion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/325Applying electric currents by contact electrodes alternating or intermittent currents for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/48785Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
    • G01N33/48792Data management, e.g. communication with processing unit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/20Applying electric currents by contact electrodes continuous direct currents
    • A61N1/30Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pathology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Physiology (AREA)
  • Endocrinology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Databases & Information Systems (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Human Computer Interaction (AREA)
  • Optics & Photonics (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Wireless equipment for confirmatory diagnosis of cystic fibrosis through sweat testing, which includes a module of analyzer / transmitter (1), with box (2), built- in microprocessor (5) for sweat induction analysis (6) through chloride measurement device (7), radio antenna (8) with a transmitter, battery (13) switch (14), and sensor card wiring connector (9) single-use, which has two iontophoresis electrodes (10), and ion-selective electrodes (11), built-in connector (12) to the module, and a module terminal / receiver (3), with box (4) desktop keyboard (15), a LCD (16) microprocessor (17), USB connections (18) for peripherals, radio antenna (21) with receiver to get data "live" from analyzer module / transmitter (1), powered by batteries or wall electrical socket. Aspects of the invention include producing a sweat sample using the principle of iontophoresis with pilocarpine.

Description

WIRELESS DEVICE FOR CONFIRMATORY DIAGNOSIS OF CYSTIC FIBROSIS
THROUGH ANALYSIS OF SWEAT CHLORIDE
BACKGROUND OF ThE INVENTION
The invention describes a wireless device for confirmatory diagnosis of cystic fibrosis, through sweat analysis, of pediatdc patients. A number of innovative and advantageous features are provided by the present invention, which will be descdbed in detail. Together they pose a significant improvement over what was already known in this field.
Cystic fibrosis is an autosomal and multisystem disease, which among other symptoms, is characterized by altered conceniration of electrolytes in secrefion.
Ps with many other diseases, their early detection is a key point for treatment, because it allows a dinical control of it, being their diagnosis confirmed by running sweat test.
In summary form, the sweat test consists of three main phases: -Producing the sweat sample. The preferred technique is recognized as iontophoresis with pilocarpine. A cholinergic drug coupled to the pilocarpine stimulates sweat glands. Sweat obtained in this way is functionally identical to sweat produced physiologically.
-Collecting the sweat sample is a very sensitive procedure. Because only a small amount of sweat is collected, it must be done without suffering any contamination and without any evaporation.
-Analysis of sweat sample. There are three groups of methods currently employed: quantitative methods require accurate measurement of sample weight, elution of the sample from absorbent gauze, and a time-consuming manual titration specific for chloride ions.
This is the classic Gibson Cooke method, which is no longer used. Ion selective electrodes have been tried, but no available equipment can perform the analysis on microliter quantities of the sample. Semi-quantitative, and non-specific methods, determine the electrolyte concentration by conductivity, and purely qualitative methods are available, based on visual analysis of color change.
For more than ten years, the field of sweat analysis has been without any kind of innovative technological advancement, rendering much of the available equipment and instrumentation obsolete.
The general problem of existing methodologies is that they are very laborious; pose a nuisance for the patient, in this case children, and lack needed sensitivity for a conclusive result.
On the other hand, all the existing equipment for analysis operated with cables connected to the patient, except those that are wireless at the stage of obtaining sweat. The system used to perform the analysis is not confirmatory, which means that instruments are inaccurate for determining the level of chloride in the analysis of sweat.
BRIEF SUMMARY OF ThE INVENTION
It should be noted, therefore, that the existence of a wireless device for measuring chloride in sweat, applied to the detection of cystic fibrosis is unknown to the inventor. A technical and structural constituency is submitted similar to those advocated by the present invention, which aims to provide answers to the problems, described above, using a method based on an ion selective electrode, which detects the ions for which they were designed. The invention also greatly decreases the problems arising from the sample's manipulation that may occur during the collection of sweat.
Specifically, the object of the invention consists of a wireless device to measure concentration of chloride in the sweat of patients with symptoms, family history, or genetic profile suggestive of cystic fibrosis. Analysis is by through ion selective electrode, using the principle of iontophoresis with pilocarpine to obtain the sweat. Unlike methods currently employed for sweat analysis, the present invention does not actually collect the sweat. It performs the measurement at the point of emission through a selective electrode, placed in the area of stimulation, and which also determines in situ the quantitative value of chloride conceniration.
Thus, the equipment proposed by the invention is by itself an obvious novelty within its scope. Accordingly, the present invention is a portable and self-contained instrument for diagnosis and confirmation of cystic fibrosis through the simultaneous use of the chloride ion selective sensors and impedance microsensors. The system is implemented for stimulating the producfion of sweat in a faster way and at lower cost. This sensitive system of detection is based on a disposable card, meaning that the invention can be a wreless apparatus for performing the sweat test.
The equipment may be comprised of two individual units.
First, there is a remote unit, which integrates the sweat generator. The device performs iontopheresis of pilocarpine, the chloride measuring electrodes, and a radio transmitter for sending the analysis information.
Second, there is a receiver unit for collecting data from the remote analyzer module, displaying and recording test results in the internal data base memory.
The remote unit may consist of a box or case, fitted with Velcro (TM) straps suitable for coupling to the body area of the patient. Electronics are incorporated inside, having a microprocessor that is responsible for doing all the tasks described above, a radio antenna for remote-unit communication, and internal wiring that connects this module with the single-use sensor card that will be placed at its base.
This disposable sensor card, at the same time, may consist of two electrodes that allow the generation of sweat by specific reagent incorporated and using the technique called iontophoresis, two electrodes that allow the analysis of the sweat generated by the iontophoresis system, capable of determining the concentration of chloride ions, and a connection port that allows the card to be connected to the module to form a single piece.
With regard to the receiver unit, the receiver unit may be composed of a desktop box or case, which houses all electronic components and provides a screen of liquid crystal display (LCD). All data is provided from the remote unit, including status indication, fault analysis, communication with peripheral devices, such as a printer and I or a computer connected to it via USB port, and a keyboard that, among other functions, allows the user to move through the menu generated by software, for example, to change setup values, such as starting points of operation, merging functions, and selecting conversion factors, in addition to assuring the proper functioning of peripheral devices.
The receiver unit also may have a radio antenna to communicate in bidirectional mode with remote unit.
This wireless equipment may confirm the diagnosis of cystic fibrosis through sweat testing suggested by the invention. A selecve ion electrode allows the user to advantageously detect the concentration of an analyte of sweat in concentrations as low as 5 mmol/l, because this electrode is designed to be highly selective, discriminating against other ions that are typically found in sweat.
This fact makes the equipment of the invention much more reliable when it has to give a reading, compared with currently used equipment based only in conductivity method, which can have more false readings due to interference in the analyte, because this system only measures the ease with which a sample of sweat allows the transport of electricfty through it. Therefore, by increasing the level of salts in the sample, the conductivity increases significantly, and although all the ionic salts are good conductors of electricily, the analyte that is required to be verified, in order to see whether a child has cystic fibrosis or not, is only found in a certain type of salt.
The new wireless equipment for confirmatory diagnosis of cystic fibrosis testing through sweat analysis, is therefore an innovative invention with structural characteristics and constituents unknown so far. Together with its practical usefulness, the present invention has sufficient basis for the privilege of exdusivity that is sought.
BRIEF DESCRIP11ON OF ThE DRAWINGS To complement the description being used and in order to provide better understanding of the characteristics of the invention, a set of drawings is accompanying this description, as an integral part thereof. The set of drawings are illustrative and not limiting.
Figure 1 shows a schematic view of the wireless equipment for confirmatory diagnosis of cystic fibrosis testing, through sweat analysis, according to the invention, which illustrate the main elements thereof.
Figure 2 shows a schematic view of the bottom of the remote unit, showing the disposable sensor card as well as the elements integrated with the card.
DETIJLED DESCRIPTION OF THE INVEN11ON
In view of the above figures and reference numerals herein, the drawings illustrate an example of a preferred embodiment of the wireless equipment for confirmatory diagnosis of cystic fibrosis testing through sweat analysis, which includes the parts that are listed and described in detail below.
Thus, as shown in Figure 1, the equipment consists of a remote unit (1), inside a box or case (2), fitted with Velcro (TM) for coupling to the body area of the patient's convenience, and a receiver unit (3), based on a benchtop box or case (4) that hosts all of its internal components and is intended to receive the data coming from remote unit (1), display and non-volatile memory, both remote and base modules are connected by radio waves.
The box (2) remote unit (1) includes an analog microprocessor (5), which is responsible for carrying out the functions of generation of sweat (6) and analysis by measuring chloride (7), a radio antenna (8) with its corresponding remote unit, and internal wiring that enables connecfion to an sensor card (9) single-use sensor, located at its base. As shown in Figure 2, two iontophoresis electrodes (10) are provided, leading pilocarpine nitrate, which penetrates the skin and stimulates sweat Two ion selective electrodes (11) enable the analysis of the sweat generated by the above iontophoresis electrodes (10), and an area of connection (12) that allows the sensor card to connect to the module.
It should be noted that the remote analyzer module I transmitter (1) is battery powered (13) and contains as well an intelligent switch (14) for the choice of several options.
For its part, the box (4) terminal I receiver (3) incorporates a keyboard (15), allowing navigation in the menu generated by the software tool, LCD screen (16) where all the data processed is displayed from analyzer module I transmitter (1), a microprocessor (17), equipped with software that controls all functions, as well as one or more USB connections (18) for peripheral devices such as a printer (19) and! or a computer (20).
The module terminal I receiver (3) also has a radio antenna (21) with its corresponding receiver module to communicate data bidirectional from the analyzer module I transmitter (1). It can be powered by a convenfional battery (not shown) or plugged into a wall socket.
Sufficiently described the nature of this invention, as well as how to implement it, it should be noted that, within its essence, can be implemented in other forms of conduct that could be different than this one used as an example, and for which the protection is sought, provided that no alteration, change or modification of its fundamental prinaple.
It could be possible to extend the system to measure others ions or substances excreted by sweat, that can be analyzed directly on the skin by direct potentiometry or any other method of analysis.

Claims (4)

  1. CLAI MS1. Wireless equipment for confirmatory diagnosis of cystic fibrosis through sweat testing, designed to measure chloride in sweat concentration by system of selective ions, using the principle of iontophoresis with pilocarpine, for sweat induction comprising: an analyzer I transmitter (1) module, fitted in a box or case (2), strapped with "Velcro" for docking in the area that suits the patient's body, incorporating sweat generator, sweat generated analyzer and data transmitter, performing the measurement direcUy into selective electrode placed on the stimulation area; and a terminal I receiver (3) module having a box or case (4) with all components inside for data reception coming from the analyzer module I transmitter (1), and to display and record the data in memory, both modules are connected by radio frequency.
  2. 2. Wireless equipment for confirmatory diagnosis of cystic fibrosis testing based on sweat, according to claim 1, characterized by the fact that the analyzer I transmitter (1) module casing (2) incorporates a microprocessor (5) to handle and perform sweat generation functions (6) and sweat testing sensor device for chloride measurement (7), a radio antenna (8) with its corresponding quantitative ion chloride concentration transmitter to the module (3), powered by cell or battery (13) and regular mains voltage socket as well as a switch (14) built with wiring that allows connection to an analyzer card (9) of a single use.
  3. 3. Wireless equipment for confirmatory diagnosis of cystic fibrosis testing in sweat, according to any previous claim, characterized by the fact that the card analyzer (9) that contact with the skin of the patient, has two iontophoresis electrodes (10), with pilocarpine nitrate, one or more selective ion electrodes (11), and connection area to the module.
  4. 4. Wireless equipment for confirmatory diagnosis of cystic fibrosis testing through sweat, according to any previous claim, characterized by the fact that the casing (4) terminal I receiver (3) incorporates a keyboard (15) to choose the menu selections generated by the software, an LCD screen (16) where all data from analyzer module I transmitter are displayed (1), a microprocessor (17), equipped with software that controls all functions, as well as one or more USB connections (18), for connecting peripherals, such printer (19) and I or a serial computer connection (20), and it also has a radio antenna (21) with its corresponding receiver module to send commands to, and receive data from analyzer module I transmitter (1), also powered by batteries or by connecting to regular wall electrical socket.
GB0919789A 2008-11-24 2009-11-12 Wireless device for confirmatory diagnosis of cystic fibrosis through analysis of sweat chloride Withdrawn GB2465464A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US12/277,273 US20100130843A1 (en) 2008-11-24 2008-11-24 Wireless device for confirmatory diagnosis of cystic fibrosis through analysis of sweat chloride

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GB0919789D0 GB0919789D0 (en) 2009-12-30
GB2465464A true GB2465464A (en) 2010-05-26

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US (1) US20100130843A1 (en)
CH (1) CH699966A2 (en)
CZ (1) CZ2009776A3 (en)
DE (1) DE102009044594A1 (en)
FR (1) FR2938744A3 (en)
GB (1) GB2465464A (en)
NL (1) NL2002819C2 (en)
SE (1) SE0950784A1 (en)
SK (1) SK500522009A3 (en)

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AU2013243541B2 (en) 2012-04-04 2017-04-06 United States Of America As Represented By The Secretary Of The Air Force Sweat simulation, collection and sensing systems
US10888244B2 (en) 2013-10-18 2021-01-12 University Of Cincinnati Sweat sensing with chronological assurance
CA2927213A1 (en) 2013-10-18 2015-04-23 University Of Cincinnati Sweat sensing with chronological assurance
CA2927211A1 (en) 2013-10-18 2015-04-23 University Of Cincinnati Devices for integrated, repeated, prolonged, and/or reliable sweat stimulation and biosensing
US11129554B2 (en) 2014-05-28 2021-09-28 University Of Cincinnati Sweat monitoring and control of drug delivery
US10639015B2 (en) 2014-05-28 2020-05-05 University Of Cincinnati Devices with reduced sweat volumes between sensors and sweat glands
EP3148430A4 (en) 2014-05-28 2018-05-16 University of Cincinnati Advanced sweat sensor adhesion, sealing, and fluidic strategies
WO2016007944A2 (en) * 2014-07-11 2016-01-14 University Of Cincinnati Combinatorial sensing of sweat biomarkers using potentiometric and impedance measurements
US20170245788A1 (en) 2014-09-22 2017-08-31 University Of Cincinnati Sweat sensing with analytical assurance
EP3244348A1 (en) 2014-10-15 2017-11-15 Eccrine Systems, Inc. Sweat sensing device communication, security and compliance
EP3256049A4 (en) 2015-02-13 2018-07-25 University of Cincinnati Devices for integrated indirect sweat stimulation and sensing
CN104835301A (en) * 2015-04-22 2015-08-12 北京柏惠维康科技有限公司 Wireless data transmission device for medical equipment
US10646142B2 (en) 2015-06-29 2020-05-12 Eccrine Systems, Inc. Smart sweat stimulation and sensing devices
WO2017044731A1 (en) * 2015-09-09 2017-03-16 University Of Cincinnati Mechanically co-located sweat stimulation and sensing
US20180317833A1 (en) 2015-10-23 2018-11-08 Eccrine Systems, Inc. Devices capable of fluid sample concentration for extended sensing of analytes
WO2017075402A1 (en) * 2015-10-30 2017-05-04 University Of Cincinnati Sweat sensing devices with electromagnetically shielded sensors, interconnects, and electronics
US10674946B2 (en) 2015-12-18 2020-06-09 Eccrine Systems, Inc. Sweat sensing devices with sensor abrasion protection
US11241174B2 (en) 2016-06-07 2022-02-08 International Business Machines Corporation Wearable device for monitoring bodily fluids
US10471249B2 (en) 2016-06-08 2019-11-12 University Of Cincinnati Enhanced analyte access through epithelial tissue
WO2018006087A1 (en) 2016-07-01 2018-01-04 University Of Cincinnati Devices with reduced microfluidic volume between sensors and sweat glands
US11832801B2 (en) * 2016-07-11 2023-12-05 Arizona Board Of Regents On Behalf Of Arizona State University Sweat as a biofluid for analysis and disease identification
US10405794B2 (en) 2016-07-19 2019-09-10 Eccrine Systems, Inc. Sweat conductivity, volumetric sweat rate, and galvanic skin response devices and applications
US10736565B2 (en) 2016-10-14 2020-08-11 Eccrine Systems, Inc. Sweat electrolyte loss monitoring devices
US11123011B1 (en) 2020-03-23 2021-09-21 Nix, Inc. Wearable systems, devices, and methods for measurement and analysis of body fluids
CN116723879A (en) * 2020-12-30 2023-09-08 佐治亚科技研究公司 Method and device for inducing sweat for medical diagnosis

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US5036861A (en) * 1990-01-11 1991-08-06 Sembrowich Walter L Method and apparatus for non-invasively monitoring plasma glucose levels
WO1999058051A1 (en) * 1998-05-13 1999-11-18 Cygnus, Inc. Monitoring of physiological analytes
US6198953B1 (en) * 1999-03-11 2001-03-06 Henry L. Webster Method and system for continuous sweat collection and analysis
US20060105420A1 (en) * 2002-08-19 2006-05-18 Tamada Janet A Compositions and methods for enhancement of transdermal analyte flux
US20060253011A1 (en) * 2005-05-09 2006-11-09 Edmonson Peter J Sweat sensor system and method of characterizing the compositional analysis of sweat fluid
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Publication number Publication date
IE20090885A1 (en) 2010-06-23
DE102009044594A1 (en) 2010-05-27
CH699966A2 (en) 2010-05-31
SE0950784A1 (en) 2010-05-25
FR2938744A3 (en) 2010-05-28
NL2002819C2 (en) 2010-05-26
CZ2009776A3 (en) 2010-08-11
SK500522009A3 (en) 2010-06-07
GB0919789D0 (en) 2009-12-30
US20100130843A1 (en) 2010-05-27

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